Archive for November, 2015

The FDA just approved the first GMO animal for human consumption – AquAdvantage Salmon. Those ideologically opposed to GMOs have predictably opposed this approval, and now are calling for labeling. Meanwhile some food outlets, like Costco, Trader Joe’s, Whole Foods, Safeway and Korger, have pledged not to sell the fish.

This is a great example of how ideological thinking leads to irrational and self-contradictory positions. Other than the fact that they were produced using genetic modification technology, these salmon are a wet dream (pun intended) of sustainable and environmentally friendly food production. ]

AquAdvantage Salmon

Salmon evolved a growth pattern that fits their seasonal migrations and their overall life cycle. There are several species of salmon, some Atlantic, some Pacific, and some exclusively fresh water. Atlantic salmon are the most common in fish farms.

From time to time courts are called upon to determine whether or not desperate patients have a right to experimental treatments. In the US we are also currently in the middle of the spread of “right to try” laws from state to state. The issue has recently come up in Brazil over patient access to an experimental cancer drug, phosphoethanolamine.

This is an unfortunate issue, because over the last century experts have developed a thoughtful system that attempts to carefully balance patient autonomy, hope for very ill or terminally ill patients, patient safety, and the good of society. Now thoughtless legislators or misguided courts are attempting to bypass this system with predictably horrible results.

However, on a superficial emotional level it is much easier to persuade people to bypass the system than respect it.

Here are the issues:

First, most experimental drugs will eventually not work. They will either fail to produce a clinically relevant result, or they will cause more toxicity than benefit. Even drugs that are promising when studied in cell cultures or animals will often fail human trials. It has to be understood, then, that what we are talking about is giving patients access to drugs that probably won’t help them and may harm them.

A new study published in PNAS explores the messaging of organizations commenting on climate change and their relationship to corporate funding. The sole author, Justin Farrell, finds that those organizations who received corporate funding were likely to network their messaging together, and to engage in a campaign of casting doubt on the scientific consensus. There was no such network among those organizations not receiving corporate funding.

Farrell notes:

“This counter-movement produced messages aimed, at the very least, at creating ideological polarization through politicized tactics, and at the very most, at overtly refuting current scientific consensus with scientific findings of their own.”

The publication of the report comes two weeks after New York prosecutors announced an investigation into whether Exxon Mobil misled the public and investors about the risks of climate change. The probe was prompted in part by reports in the Los Angeles Times and the online publication Inside Climate News, alleging that Exxon researchers expressed concerned about climate change from fossil fuel emissions decades ago, even as the company publicly raised doubts about whether climate-change was scientifically valid.

This should come as no surprise to those following the climate change debate. Climate change and other issues, in fact, challenge the very notion of scientific consensus and what it means, but also demonstrate why we should listen to a robust consensus.

One of the pillars of alternative medicine propaganda is historical revisionism. Proponents often claim that they were ahead of the curve on diet and exercise advice, while the medical establishment lagged behind. They go as far as to take credit for the entire field of nutrition by labeling it “alternative.”

The fact is, the disparity between mainstream and alternative advice has not changed much for the past 60+ years. There are even some elements that are literally centuries old – using “natural” as a marketing angle, for example.

The alternative narrative is not based on reality, however. Fortunately we have records from the first half of the 20th century that document exactly what the scientific mainstream and alternative culture were saying. It is a good idea to frequently question your own narrative and check the actual facts. I sought to find some historical documents that would demonstrate what the medical mainstream were saying in the 1950s.

Crowdfunding is an excellent application of social media and the web. Anyone with a great idea, who can sell their idea, can get funding from the public. You don’t necessarily need big investors.

But of course, any tool or application that can be used for good can also be used for ill. Crowdfunding sites have been used to fund pure pseudoscience. A recently example was sent to me by a reader – Vitastiq. The campaign was 185% funded, for over $210,000.

What the product claims to do is measure vitamin and mineral levels non-invasively by simply touching a small probe against a specific location on the skin. I was immediately skeptical of these claims – how can the blood level of vitamin B12, for example, be measured on the skin? Further, the probe just has a simple electrical conductor. At best it is measuring skin conductance, which can be used to measure sweat levels but not much else.

A Chinese team of researchers recently announced that they attempted to edit the genes in human embryos with the genetic disease beta-thalassemia. They used the CRISPR-Cas9 technology, which they said was not successful enough in this application to be used. Some of the embryos resulted in mosaics, with only some of the cells being fixed, and other resulted in unwanted mutations.

While the attempt to fix the genetic disease in embryos was unsuccessful, the announcement has prompted discussion over the ethics of gene editing in humans.

CRISPR

First for some background, because I have not yet written about the CRISPR technology, this is an exciting gene-editing technology that allows for rapid, accurate, and inexpensive gene editing.

In the last few years autonomous cars have seemed to turn a corner – suddenly the technology is here. This is one of those technologies that was long anticipated, and then quickly arrived. They are not yet in mass production, but it feels like we are on the steep part of the curve.

Google car is the most in the news. The company has been testing their autonomous vehicle for years. Some use the term “driverless” but there still needs to be a human in the driver’s seat. The success of the vehicle is measured in how often the driver needs to intervene. At first they measured interventions per mile, and now they measure miles per intervention.

The autonomous car is certain to be a transformative technology. I can’t see how it won’t. It will transform the way we get around, could spawn new industries, and may also transform our infrastructure. For example, imagine a fleet of truly driverless cars you can summon with an app, Uber-style. Insert your credit card, and you’re off. For some people this may obviate the need to own a car.

Right now we are trying to adapt autonomous cars to our existing infrastructure. Eventually we will adapt our infrastructure to autonomous cars. At present the goal is to get the cars to drive more like humans. For example, recently a Google car was pulled over for driving too slowly. The algorithm called for the car to drive very cautiously (never more than 25 mph). This resulted in a back-up of traffic. Google now says they endeavor to make the cars drive more like people (at least in some ways).

David Katz is a prominent proponent of integrative medicine. We in the science-based medicine (SBM) community have on several occasions over the last seven years critically addressed some of his claims, for the purpose of public intellectual discourse on topics of vital interest to the public, namely health care. When Katz has responded, he has typically done so by attacking a strawman rather than the actual SBM position.

He has now done so again, in a transparent fashion. I suspect he is responding to our criticism of him from a couple of week ago. He has now written an article in the HuffPo in which he makes specific claims about SBM that are demonstrably false. When criticizing some one or group who advocates a position with which you disagree, it is critical to be fair, even charitable, to their position. At the very least you should endeavor to properly understand the position you are criticizing. Failing to do so falls somewhere on the spectrum from intellectually dishonest to lazy. Usually the pre-existing narrative holds sway and runs roughshod over the evidence, even when in plain sight.

Katz in his recent article is responding to an article in JAMA that reviews 10 standard practices the authors believe are not supported by evidence and should be questioned. This is exactly the kind of process that we support at SBM – examining all practices from a science-based point of view. The first half of Katz’s article is also quite reasonable, and in fact is something that could easily be found on the pages of SBM.

He did not stop there, however, and used the opportunity to go on a tear against SBM and in defense of his beloved Integrative Medicine. Here is where he goes south:

At the same time, and equally important, a certain sanctimony about evidence-based medicine results in contemptuous disregard for the “unconventional.” This broad designation may, at times, refer to so-called “alternative” medicine, where detractors will suggest one is headed toward voodoo. But it also refers to lifestyle interventions that are very far from the worrisome realm of “woo.”

Katz repeats the common CAM (complementary and alternative medicine) fiction that lifestyle factors are unconventional. This is nonsense, easily debunked by simply looking at historical evidence. Scientific conventional medicine identified the relationship between specific lifestyle factors and disease risk. Lifestyle recommendations have been slowly phased into convention medicine as the evidence has come to light. Sure, this has happened slower than we would have liked – in general the medical profession is slow to adapt to the evidence. They come around eventually, but we do need to explore ways to make this process happen more quickly. In any case, CAM does not own lifestyle factors. They have simply appropriated them to have some legitimate footing to their entire endeavor.

The rest of his statement needs to be put into the context of what he also says in the article:

If evidence matters, it matters equitably, and universally.

This has been a persistent theme of David Katz – accusing critics of CAM of having a double standard. The opposite is the truth. SBM specifically calls for one universal science-based standard of care. That is our very publicly and frequently stated position.

It is the proponents of CAM who are explicitly calling for a double standard. Health care freedom laws are about creating a double standard for CAM therapies. The National Center for Complementary and Integrative Health is about creating a double standard for CAM research funding. Dr. Katz himself has called for “a more fluid concept of evidence” when considering CAM.

The fact is, when held to the light of science, CAM therapies do not hold up well. That is precisely why they are alternative. Proponents don’t acknowledge this, so they have to create the fiction that CAM therapies are being treated unfairly. Katz repeats that accusation here:

In other words, the prevailing pattern is that “we” (i.e., conventional medicine) are innocent until proven guilty, but everyone else is guilty until proven innocent. No special olfactory acuity is required to discern how bad that smells.

What Katz is referring to here is not a double standard but simply considering scientific plausibility or prior probability. Katz has directly criticized the use of scientific plausibility in evaluating medical treatments. He is wrong, but at least here he is discussing the actual issue at hand.

It is true that conventional medicine will often use a treatment because it seems plausible before there is adequate evidence to show that it actually works. That, more than anything, is the central criticism put forth by the evidence-based medicine movement. EBM specifically eliminates considerations of plausibility in order to avoid this error.

SBM recognizes the problem but does not take that approach. Rather, we argue that treatments should be based on both scientific plausibility and rigorous clinical evidence. At the very least the clinical evidence needs to be put into the context of scientific plausibility.

Another way to look at the difference between SBM and EBM is that EBM tends to follow more of a frequentist statistical approach (with its over-reliance on p-values) while we prefer more of a Bayesian approach. The latter begins with prior probability and then evaluates the effect that any new clinical evidence has on that probability. In this way SBM advocates looking at all the scientific evidence to come to one overall conclusion about the likelihood that a treatment has benefits in excess of risks.

We advocate applying this standard to all of medicine.

I honestly don’t mind that Katz disagrees with us and advocates a different approach. Let’s have it out in open discussion. That is how better ideas prevail. I do mind when he mischaracterizes what SBM does and stands for. This is what he does here:

To the best of my knowledge, a rather boisterous group in cyberspace calling itself “science based medicine” is silent on all of this. They preferentially malign all alternatives to conventional medicine, implying that problems of evidence and its application lie entirely without, and not within. This, in turn, makes it clear that such protest is itself unconcerned with the underlying evidence, and born instead of ideological zealotry. If evidence matters, it matters equitably, and universally.

The link on SBM is not to SBM but to the recent article he wrote essentially calling us fools and fanatics (to which David Gorskiand I responded two weeks ago).

Prefacing his claim with “to the best of my knowledge” does not save Katz from criticism for making a blatantly untrue statement. He is saying that SBM is silent when it comes to criticism of mainstream medicine. I am not saying that Katz should be highly familiar with the thousands of articles we have published on SBM. But even a casual perusal shows this claim to be false.

He could have also plugged something like “cancer screening” into the search window on SBM. He would have been greeted with 190 articles, most of which are discussing mainstream cancer screening practice. This was one of the actual topics of the JAMA article, and ironically David Gorski has addressed the very issue on SBM.

Just for fun I looked at the most recent 60 articles on SBM. Forty of them dealt with CAM, pseudoscience, science denial, a fringe treatment, or the regulation of fringe treatments or professions. That is undoubtedly our expertise and focus at SBM. However, 10 articles dealt with criticism of mainstream practice, 3 dealt with the nature of medical evidence itself, and 6 were about other topics. That is 10 articles in the last couple of months that Katz says “to the best of my knowledge” don’t exist. Often “to the best of my knowledge” means “I never bothered to look.”

In addition to being demonstrably factually wrong, Katz draws the wrong conclusion from his confirmation bias. He thinks it is “clear” that our focus on alternative treatments is due to “ideological zealotry.” This is a common tactic of CAM proponents – they try to depict the defenders of a reasonable standard of evidence as the zealots, while those trying to sell treatments based on magic and pseudoscience are just being “open-minded.”

We are actually quite open about our editorial policy. We focus on pseudoscience, unconventional treatments, and fringe claims for very good reasons.

1 – In establishing what the standard of science and evidence in medicine should be, it is useful to shine the light on the most egregious violators.

2 – The mainstream media does a generally poor job of reporting on fringe topics, falling for false balance, citing outliers as experts, and hyping sensational claims. We are filling a gap and correcting a great deal of bad science reporting.

3 – Understanding pseudscience is a specialty unto itself that requires specified knowledge. This knowledge is generally lacking in mainstream science and academia. That is our specialty, so of course we focus on it.

4 – Mainstream medicine already has an infrastructure of experts examining and commenting on practice and evidence. Our efforts there would largely be redundant. When we feel they aren’t, we comment.

The core of SBM, however, is an examination of the nature of scientific and clinical evidence, and the relationship between that evidence and the practice of medicine. We feel we have a very solid position, and Katz has failed to criticize it in any meaningful way. Instead he and others attack predictable and rather tired straw men.

In fact Katz’s entire article is just another iteration of the tu quoque logical fallacy common in CAM circles – trying to avoid criticism of CAM practice by saying that mainstream medicine has problems of its own.

In fact this is where Katz gets it most wrong – in his musings about how to fix the shortcomings of mainstream medical practice. He writes:

The cleanup will certainly not come courtesy of those calling themselves “science-based,” who live within its glass walls, tossing stones outward. They produce nothing more useful than shards of glass.

It will come courtesy of those who concede, with suitable humility, that no single domain of influence has a monopoly on dirty boots. It will come courtesy of those who like a level playing field, and respect the potential for baby and bathwater in any given tub.

This is a massive exercise in rewriting history and missing the point. SBM is, in fact, the solution to the problems he discusses. SBM is about being humble before the evidence. What I call “neuropsychological humility” is a major theme of scientific skepticism, of which SBM is a part.

I and my colleagues have written many articles on SBM about how we need to increase the standard of evidence across the board. There are too many published false-positive studies, there is publication bias and citation bias, exploitation of researcher degrees of freedom, a problem with open-access journals, a reluctance to publish exact replications, a need for greater transparency, perhaps a rethinking of peer-review, and an overall problem of prematurely adopting new treatments with later reversals. These are all criticisms of mainstream medicine. To claim we do not address this issue is astounding.

Even more astounding is the fact that within CAM all of these problems are exacerbated, by orders of magnitude. The problems with conventional medicine that Katz criticizes are far worse in the world of CAM. It is difficult to take him seriously about “cleaning house” in mainstream medicine while he is simultaneously trying to give a free pass to his “integrative medicine.” He decries a double standard, while trying to create one. He calls for humility, while CAM at its very core is based on the hubris that personal experience and wisdom trump scientific evidence.

Conclusion

David Katz has his narrative – he believes in ancient wisdom and natural therapies, and would like for them to be integrated into mainstream medicine. The problem with this position is that there is no particular reason to suspect that ancient practices were based in reality, and there is no reason to think that the very vaguely defined “natural” is an advantageous property to have.

Unsurprisingly, when actually subjected to rigorous clinical study, treatments that are not based on scientific plausibility but instead on romantic notions of ancient wisdom and benign nature, turn out to be largely worthless. They don’t work.

Faced with this stark reality, proponents of integrative medicine have been doing a furious dance, trying to distract from the facts. They have attacked the messenger, and applied an impressive array of distractions and logical fallacies. Katz has become quite adept at this dance.

His criticisms all miss the mark, and in some cases are factually incorrect.

We could have a meaningful discussion of the optimal relationship between basic science, clinical science, and best medical practice. First, however, he would need to dispense with his obvious straw men positions, and acknowledge his factual errors.

The British National Health Service (NHS) is considering blacklisting homeopathy prescriptions from general practitioners. While this would have an overall small effect on the homeopathy market, it is politically potentially very significant.

The NHS currently spends about £4m on homeopathy each year, of which only £110,000 is from GP prescriptions. The rest is from homeopathic hospitals (yes, hospitals). The real market, however, is in over the counter homeopathic products.

In the UK, Europe and the US homeopathy has ballooned into a multi-billion dollar industry. It is now potentially, it seems, the victim of its own success. When it was smaller it essentially flew under the radar – regulators and politicians didn’t think it was worth spending political capital to reign in a fringe treatment that people either wanted or did not know or care about.

In the US the FDA specifically decided to let the homeopathic industry regulate itself, because it was simply too small for them to spend their resources on. That has now changed.

A new video is making the rounds on social media making the incredible claim that you would have to eat five grocery store apples today to equal the nutrient density (not calories, but other nutrients) of a grocery store apple from 1936. The video makes a second claim, that the decrease in nutrient density is due to poor soil. The video is little more that pro-organic propaganda, and neither claim is sourced – because they are not true.

However, the story of nutrient density of fruits and vegetables is a complex and interesting one. It is interesting to compare food plants from thousands of years ago (prior to any cultivation), 100 years ago, and today. First we need to ask – what are the differences? Then we can try to explain them.

Recent studies of historical nutrient content data for fruits and vegetables spanning 50 to 70 years show apparent median declines of 5% to 40% or more in minerals, vitamins, and protein in groups of foods, especially in vegetables.

So there does appear to be a real decline, although not the 80% across the board suggested by the pro-organic video. The declines are significant for vegetables, and less so in fruits (so apples was a poor example to use). Averaging out all the declines, you get about a 20% decline in nutrient density for produce.